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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Hemoglobin Quantitation
510(k) Number K955283
Device Name PRIMUS VARIANT SYSTEM PVS99
Applicant
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64113
Applicant Contact JIM NOFFSINGER
Correspondent
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64113
Correspondent Contact JIM NOFFSINGER
Regulation Number864.7415
Classification Product Code
GKA  
Date Received11/16/1995
Decision Date 03/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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